BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALIGHT ST MESH

    MDR report key: 2892213 · Received December 21, 2012

    Report

    Report Number
    1213643-2012-00900
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    November 30, 2012
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE DEVICE FOUND TO BE SOME TYPE OF HERNIA REPAIR PATCH. ONE SIDE OF THE EXPLANT HAD A SUBSTANTIAL AMOUNT OF TISSUE ATTACHED TO IT. THE OTHER SIDE OF THE EXPLANT HAD VERY LITTLE TISSUE ATTACHMENT. THE EXPLANT WAS SOMEWHAT ELLIPTICAL IN SHAPE. IT MEASURED APPROXIMATELY 8.5¿ AT ITS LONGEST POINT AND 6.75¿ AT ITS WIDEST POINT. THERE WERE NUMEROUS FIXATION COILS/TACKS AROUND THE OUTER EDGE OF THE EXPLANT. THERE WERE ALSO NUMEROUS FIXATION COILS/TACKS IN AND AROUND THE MIDDLE OF THE EXPLANT. THERE WAS A PUCKER IN THE CENTER OF THE EXPLANT THAT MEASURED APPROXIMATELY 1.5¿ AT ITS PEAK HEIGHT. THE PUCKER WAS SOMEWHAT RECTANGULAR IN SHAPE AND MEASURED APPROXIMATELY 3.0¿ X 3.5¿ (10.5 SQUARE INCHES). CURRENTLY, NO DEFINITIVE CONCLUSION CAN BE DRAWN. IT WAS REPORTED THE PATIENT DEVELOPED AND WAS TREATED FOR A RECURRENCE WHICH IS A KNOWN ADVERSE EVENT LISTED IN THE IFU. THE PRODUCT WAS ORIGINALLY REPORTED AS A SEPRAMESH IN WHICH IS RECTANGLE IN SHAPE. THE RETURNED DEVICE WAS OVAL IN SHAPE AND DOES NOT MATCH THE SIZING OR SHAPE OF A SEPRAMESH PRODUCT. PRODUCT IDENTIFIERS HAVE NOT BEEN PROVIDED THEREFORE A MFG REVIEW IS NOT POSSIBLE. BASED ON THE SAMPLE EVALUATION AND THE LIMITED INFO PROVIDED, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY A SALES REP: IT IS ALLEGED THE PATIENT HAD A SEPRAMESH IMPLANTED FOR VENTRAL HERNIA REPAIR TWO TO THREE YEARS AGO. THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR EXPLANT OF THE SEPRAMESH DUE TO A RECURRENCE WHERE THE MESH ¿BALLOONED INTO THE DEFECT.¿ THE DEFECT WAS REPAIRED WITH COMPONENT SEPARATION AND USE OF A XENMATRIX. DETAILS OF THE CASE ARE UNCLEAR AT THIS TIME. BASED ON THE SAMPLE EVALUATION (SIZE AND SHAPE) AND CUSTOMER ORDER HISTORY THE PRODUCT RETURNED IS AN UNKNOWN VENTRALIGHT ST MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRALIGHT ST MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention